Novel Agent Begins STARLIGHT-1 Dose Expansion in Relapsed/Refractory B-Cell NHL

The first patient has been dosed in the dose-expansion phase of the phase 1/2 STARLIGHT-1 trial (NCT06343311) evaluating EB103, a CD19-redirected ARTEMIS T-cell therapy, in adults with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL), according to a news release from Estrella Immunopharma.¹

The company also reported that, among evaluable patients from the phase 1 dose-escalation portion of the trial without central nervous system (CNS) involvement, all patients who achieved a complete response (CR) remained in CR at the 6-month assessment.

What is EB103, and how does it differ from CAR T-cell therapy?

EB103 uses ARTEMIS technology to target CD19, a protein expressed on the surface of nearly all B-cell leukemias and lymphomas. Unlike a conventional chimeric antigen receptor (CAR) T-cell construct, an ARTEMIS T-cell is designed to be activated and regulated through a cellular mechanism that more closely resembles that of an endogenous T-cell receptor once it engages a cancer target. The company is also developing EB104, a second ARTEMIS-based T-cell therapy designed to target both CD19 and CD22, another protein expressed on most B-cell malignancies.

What does the dose-expansion phase involve?

The expansion phase is designed as a multicenter, open-label study intended to further evaluate the safety and efficacy of EB103 at the recommended phase 2 dose (RP2D) in patients 18 years and older with R/R B-cell NHL. Data from this cohort will be used to determine the pivotal trial strategy for EB103.

STARLIGHT-1 is an open-label, dose-escalation, multicenter phase 1/2 trial designed to assess the safety of EB103 and determine its RP2D, structured as a dose-escalation phase followed by the current expansion phase; the trial began enrolling in June 2024, with an estimated primary completion date of December 2026.²

The primary end points of the trial included the incidence of dose-limiting toxicities and treatment-emergent AEs, as well as determining the RP2D in the phase 1 portion of the study. Secondary end points included overall response rate, disease control rate, duration of response, progression-free survival, event-free survival, overall survival, and pharmacokinetics.

What supporting safety and efficacy data preceded the expansion phase?

The move to the expansion phase follows a review by an independent data safety monitoring board (DSMB) of data from the phase 1 dose-escalation portion of STARLIGHT-1. As of that December 2025 review, no treatment-related serious adverse effects (AEs) had been reported among 9 patients treated in the dose-escalation phase, including high-risk patients who were not eligible to receive commercially available CD19-directed cell therapies.³ Based on this safety profile, the DSMB recommended advancing the trial to the expansion phase at the RP2D.

Earlier, in the second dose-escalation cohort, all evaluable patients achieved a CR at the month 1 assessment, a group that included 1 patient with CNS lymphoma.⁴ No treatment-related serious AEs were reported in that cohort. Taken together with the durability of response, this dose-escalation experience forms the basis for the company's decision to proceed to dose expansion.

How does EB103 fit into the broader CD19-directed cell therapy landscape?

Several CD19-directed CAR T-cell therapies are already commercially available for relapsed/refractory B-cell NHL, but not all patients are eligible for them, including some with CNS involvement or other high-risk disease features. Cheng Liu, PhD, chief executive officer of Estrella, said the dosing of the first patient in the expansion phase marks an important step for the STARLIGHT-1 program.

“The sustained [CRs] observed to date reinforce EB103’s potential to deliver best-in-class outcomes for patients with [relapsed/refractory] B-cell NHL,” Liu stated in the press release.¹ “We remain deeply committed to advancing EB103.”

References

1. Estrella Immunopharma announces first patient dosed in dose-expansion phase of STARLIGHT-1 trial and reports durable response rate in advanced B-cell non-Hodgkin’s lymphoma. News release. Estrella Immunopharma, Inc. July 24, 2026. Accessed July 24, 2026. https://tinyurl.com/mrxtye34
2. T-cell therapy (EB103) in adults with relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL) (STARLIGHT-1). ClinicalTrials.gov. Updated August 7, 2026. Accessed July 24, 2026. https://tinyurl.com/hs7sxx4h
3. Estrella advances STARLIGHT-1 trial into phase II following positive DSMB recommendation. News release. Estrella Immunopharma, Inc. December 4, 2025. Accessed July 24, 2026. https://tinyurl.com/4h3u8u82
4. Estrella Immunopharma completes second dose cohort in STARLIGHT-1 trial of EB103 with complete responses in all evaluable patients. News release. Estrella Immunopharma, Inc. November 3, 2025. Accessed July 24, 2026. https://tinyurl.com/2ubuhwbn